KR20210065132A - Systems and methods for repairing soft tissue tears - Google Patents

Abstract

A system and method for soft tissue tears, such as meniscus tears. The anchor system has a first implant connected to the suture strand. The suture strands are folded such that the tension limb extends from the first implant and the lock rim extends from the first implant. The anchor system also includes a second implant secured to a locking rim and an adjustment mechanism at the suture strand between the first and second implants. The tension limb is passed through an adjustment mechanism. This creates an accommodation loop in the suture strand extending from the accommodation mechanism through the first implant. The adjustment loops are one-way adjustable loops for movement for the first implant and the second implant respectively into positions relative to each other.

Description

Systems and methods for repairing soft tissue tears

FIELD OF THE INVENTION The present invention relates generally to surgical tools and instruments and, more particularly, to a system and method for repairing soft tissue tears, such as meniscal tears.

The meniscus is a piece of cartilage located within the knee joint, between the upper and lower tibia and lower than the femur. The meniscus enables stable movement of the tibia and femur with respect to each other, and provides shock absorption and load distribution. The meniscus is frequently damaged (eg torn) as a result of injuries and/or accidents. A damaged meniscus can interfere with proper movement of the knee joint and cause pain, among other problems.

More particularly, the critical role of the intact meniscus, and its importance for proper knee function, has been well documented and accepted by the general orthopedic community. An intact and functioning meniscus is critical to optimally distribute the weight-bearing forces transmitted through the knee joint while maintaining knee stability. The meniscus is also essential for preserving the articular cartilage surfaces of the knee. Loss of meniscus tissue is considered a major precursor to the development of knee osteoarthritis.

The main task of repairing a torn meniscus is the fact that the tissue itself is a fibrous structure rather than a uniformly vascular one. The vascular zones of the meniscus contain about one-third of the meniscus tissue and are generally recognized as "red-red" and "red-white" zones. The "red-red" zone (ie, the most highly vascularized portion of the meniscus) is the area known to readily recover from meniscus repairs and is along its outer periphery. The “red-white” zone extends from most of the vascular region towards the medial portion of the meniscus, where the blood supply ultimately decreases to non-vascular (also referred to as the “back-back” zone). Proper surgical technique is believed to be paramount if successful recovery is to be achieved in the "red-white" zone. About 15% of all meniscus tears occur in the "red-red" zone, 15% of other meniscus tears occur in the "red-white" zone, and 70% of the remaining meniscus tears are in the "one hundred-and-a-half" (or It is generally accepted knowledge that it occurs in areas without blood vessels.

Another important challenge in repairing torn meniscus is that the tears vary in size and shape, making shrinkage and apposition of the torn tissue difficult to achieve. Without proper attachment and stability, torn meniscus tissue will not properly repair.

The technology to repair torn meniscus tissue was first developed and pioneered by early sports medicine-focused surgeons through the 1980s. Early methods used only sutures for repair. The technique of "inside-out" and "outside-in" sutures has become the so-called "gold standard" for the repair of valve tissue. Both of these techniques pass a small diameter suture (size 2-0 or 3-0) through the meniscus to fix and stabilize the tear, reduce and close the tear, and then knot the suture over the knee capsule. Concentrated on tying the knot. A characteristic of all these early suture repairs is that the suture knot is on the outside of the knee joint, and the use of needles and sutures allows the surgeon considerable flexibility in properly reducing and stabilizing tearing, so that the surface of the valve is relatively smooth. ) is maintained.

Eventually, these early surgeons began the concomitant use of complementary techniques to promote vascular responses in the more non-vascular areas of the meniscus. In methods such as rasping of torn edges and meniscus, interpositional blood clots, trephination to create vascular channels, and fascial sheaths or synovials from which synovial fluid is secreted Application of flap convergence has been shown in considerable studies to be 150% more effective in the treatment of torn meniscus compared to repairs without the use of these concomitant techniques.

The specific issues and challenges associated with all of the aforementioned in-outer and out-of-suture repair techniques are those related to the "user interface" and "tethering" of the meniscus into the knee capsule. mainly focus on More specifically, the "user interface" problems generally meet the technical demands required in the operating room: safely passing the needle and suture from the anterior position of the meniscus through the posterior position of the meniscus and exiting through the posterior/internal side of the knee joint. exit (i.e., the so-called "inside-out" technique); or pass a needle and suture from the outer inner side of the knee through the meniscus into the knee joint and withdraw and reinsert behind the meniscus, then through the capsule It is related to the surgeon's skill and number of assistants required to re-pass to the medial side of the knee (ie the so-called "outer-in" technique). Since the evidence suggests that tethering these meniscus into the knee capsule may interfere with the normal biomechanics of the meniscus, the aforementioned tethering issues fix the sutures over the knee capsule and thus attach the meniscus to the knee capsule. It is related to more recent concerns about "tethering" to (eg, distribution of loads and forces, etc.).

As awareness of the importance of meniscus increased in the late 1980s, new methods of meniscal repair were developed. These new methods focused on improving the implementation of the procedure to achieve it more easily, simply and quickly. The new gold standard approach has come to be referred to as the so-called "all-inside" technique. The all-medial technique is intended to neither destroy the knee capsule nor require any incision on the posterior/internal side of the knee (ie, as required for the medial-outer and lateral-internal suture techniques discussed above). do. With the all-medial technique, full restoration of both approximation and fixation is performed intra-articularly.

The first all-medial restoration devices are inserted through a standard arthroscopic portal and then forcefully pushed through the meniscus, across the tear, tack-like to close and secure the tear without sutures. ) implants. These tack-like implants are formed from biomaterials such as PLA, PLLA or PGA, which are expected to biodegrade over time. However, it has been found that these materials are very hard when first inserted and, in use, degrade or bioabsorb much more slowly than expected. As many published studies report device failures that can lead to tear reformation, loose implants in the knee joint, and articular cartilage damage, clinical use and follow-up are We have demonstrated the inherent risks associated with the use of implants such as tacks in the knee joint. Moreover, it can be a challenge for a surgeon to adequately address a variety of tear shapes and sizes using such tack-like implants.

As a result, attention has returned to suture-based restorations, with a new focus on performing suture-based restorations using all-internal techniques. There are several recent systems that seek to achieve these goals. However, these systems have not been found to be completely satisfactory.

Therefore, there is a need for new and improved methods and devices for meniscus repair.

Description of Related Art Section Disclaimer: To the extent that certain patents/publications/products are discussed above or elsewhere in this disclosure above the description of this Related Art Section, these discussions refer to the discussed patents/ It should not be taken as a position that publications/products are prior art for patent law purposes. For example, some or all of the patents/publications/products discussed may not be initially sufficient, may not sufficiently reflect the initially developed subject matter, and/or be sufficiently prior art for patent law purposes. It may not be possible enough. To the extent specific patents/publications/products are discussed above this description of the relevant technical section and/or throughout this application, all descriptions/disclosures are hereby incorporated by reference herein in their entirety. do.

Embodiments of the present invention relate to a system or method for repairing soft tissue tears, such as tears of the meniscus. According to one side, the anchor system has a first implant connected to a suture strand (length of suture). The suture strand is folded such that a tensioning limb extends from the first implant and a locking limb extends from the first implant. The anchor system also includes an adjustment mechanism at the second implant secured to the locking rim and the suture strand between the first and second implants. The tension limb passes through an adjustment mechanism.

In another aspect, the present invention is a delivery device. The delivery device includes an elongated body with a needle and a pusher assembly within the elongated body, the needle extending distally from the elongated body. The pusher assembly has a cannulated pusher rod extending distally from the pusher body and an actuator extending from the pusher body through the elongated body. The intubation pusher rod may slide within the needle. The delivery device also includes a locking mechanism on the elongated body that is movable between a locked position and an unlocked position. When the locking mechanism is in the locked position the actuator can move from the first configuration to the second configuration and when the locking mechanism is in the unlocked position the actuator can move from the second configuration to the third configuration.

In another aspect, the present invention is a method for meniscus repair. The present invention relates to (i) an elongated body having a needle, the needle extending distally from the elongated body, a pusher assembly in the elongated body, the pusher assembly extending distally from the pusher body and from the pusher body through the intubated pusher rod and providing a delivery device comprising an actuator that extends, wherein the intubation pusher rod is slidable within the needle, and a locking mechanism on the elongated body, wherein the locking mechanism is movable between a locked position and an unlocked position; (ii) a first implant connected to a suture strand, wherein the suture strand is folded such that a tensile rim extends from the first implant and a locking rim extends from the first implant; a second implant secured to the locking rim; and the first implant and the second implant 2 providing an anchor system having an adjustment mechanism at the suture strand between the implants, wherein the tension rim is passed through the adjustment mechanism; (iii) positioning the needle at the first piercing site on the first side of the tissue; (iv) piercing the needle through the first piercing site to the second side of the tissue; (v) distally moving the actuator, deploying the first implant from the delivery device; (vi) removing the needle from the first piercing site on the first side of the tissue; (vii) positioning the needle at a second piercing site on a second side of the tissue;

(viii) piercing the needle through the first piercing site and into the second side of the tissue; (ix) moving the locking mechanism from the locked position to the unlocked position; and (x) distally moving the actuator further away, deploying the second implant from the delivery device.

These and other aspects of the invention will become apparent and elucidated with reference to the embodiment(s) which will be described later.

One or more aspects of the invention are specifically pointed out and expressly claimed by way of example in the claims at the conclusion of the specification. The foregoing and other objects, features, and advantages of the present invention are apparent from the following description in conjunction with the accompanying drawings.
1 is a side perspective view, a schematic representation of an anchor system according to an embodiment;
Fig. 2 is a schematic representation of a perspective view of an implant of an anchor system according to an embodiment;
3A is a perspective view that is a schematic representation of a first step of creating a pierce hitch in a suture according to an embodiment.
3B is a perspective view of a schematic representation of a second step of creating a pierce hitch in a suture according to an embodiment.
3C is a perspective view of a schematic representation of a third step of creating a pierce hitch in a suture according to an embodiment.
3D is a perspective view of a schematic representation of the final step of creating a pierce hitch in a suture according to an embodiment.
4 is a perspective view of a schematic representation of a suture strand connected to a second implant according to an embodiment.
5 is a perspective view of a schematic representation of an anchor system in a pre-deployment configuration according to an embodiment;
6 is a perspective view of a schematic representation of an anchor system in a pre-deployment configuration according to an embodiment;
7 is a side view of a schematic representation of an anchor system according to an alternative embodiment;
8 is a perspective view of a schematic representation of the anchor system of FIG. 7 ;
9 is a perspective view of another schematic representation of the anchor system of FIG. 7 ;
Fig. 10 is a perspective view of a schematic representation of an anchor system according to another alternative embodiment;
11 is a perspective view of a schematic representation according to an embodiment of a delivery device;
12 is a perspective view of a schematic representation of a pusher assembly of a delivery device according to an embodiment;
13 is a side view of a schematic representation of a delivery device in a first configuration according to an embodiment;
14 is a side view of a schematic representation of a delivery device in a second configuration according to an embodiment;
15 is a side view of a schematic representation of a delivery device with a locking mechanism in an unlocked position according to an embodiment;
Fig. 16 is a side view of a schematic representation of a delivery device in a third configuration according to an embodiment;
Fig. 17 is a side view of a schematic representation of a delivery device in a third configuration according to an embodiment;
18 is a top view of a schematic representation of a delivery device according to an embodiment;
19 is a side view of a schematic representation of a delivery device according to an embodiment;
20 is a cross-sectional side view of a schematic representation of a delivery device according to an alternative embodiment;
Fig. 21 is a cross-sectional side view of a schematic representation of a delivery device in a first configuration according to an alternative embodiment;
22 is a cross-sectional side view of a schematic representation of a delivery device in a second configuration according to an alternative embodiment;
23 is a top view of a schematic representation of an anchor system in a deployed configuration according to an embodiment;
Fig. 24 is a top perspective view of a schematic representation of an anchor system in a deployed configuration according to another embodiment;
Fig. 25 is a top perspective view of a schematic representation of an anchor system in a deployed configuration according to an alternative embodiment;
26 is a side perspective view of a schematic representation of an anchor system in a deployed configuration according to an embodiment;
27 is a top perspective view of a schematic representation of an anchor system in a deployed configuration according to an embodiment;
28 is a top perspective view of a schematic representation of an anchor system in a deployed configuration according to an embodiment;
29 is a top perspective view of a schematic representation of a delivery device deploying an anchor system according to an embodiment;
30 is a top perspective view of a schematic representation of a delivery device deploying an anchor system according to an embodiment;
31 is a top perspective view of a schematic representation of a delivery device deploying an anchor system according to an embodiment;
32 is a top perspective view of a schematic representation of a delivery device deploying an anchor system according to an embodiment;
33 is a top perspective view of a schematic representation of a delivery device deploying an anchor system according to an embodiment;
34 is a top perspective view of a schematic representation of a delivery device deploying an anchor system according to an embodiment;
35 is a top perspective view of a schematic representation of a delivery device deploying an anchor system according to an embodiment;
Fig. 36 is a top perspective view of a schematic representation of an anchor system in a deployed configuration according to an embodiment;
37 is a top perspective view of a schematic representation of an anchor system in a deployed configuration according to an embodiment;
38 is a top perspective view of a schematic representation of an anchor system in a deployed configuration according to an embodiment;

This application was filed on September 28, 2018 and is entitled "System and Method for Repairing Soft Tissue Tears," serial number of U.S. Provisional Patent Application. 62/738,551 (U.S. Provisional Patent Application No. 62/738,551), a U.S. Provisional Patent Application Serial No. filed on January 11, 2019 and entitled "System and Method for Repairing Soft Tissue Tears." 62/791,127, and U.S. Provisional Patent Application Serial Numbers, filed December 20, 2018, and entitled "Systems and Methods for Repairing Soft Tissue Tears." 62/782,689 claim priority.

Aspects of the invention and specific features, advantages, and details thereof are more fully described below with reference to non-limiting examples shown in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the invention in detail. However, it is to be understood that, while representing aspects of the invention, the details and specific non-limiting examples have been given by way of illustration only and not by way of limitation. Various substitutions, modifications, additions, and/or arrangements within the spirit and/or scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure.

Referring now to the drawings, like reference numerals refer to like parts throughout, and FIG. 1 shows a side perspective view, which is a schematic representation of an anchor system 100 according to an embodiment. Anchor system 100 includes first implant 102 and second implant 104 interconnected by suture 106 strands. The suture 106 strand terminates at a first end 120 and a second end 122 . By creating a one-way adjustable loop through the adjustment mechanism 108 and the locking mechanism 116 , the suture line 106 strands are connected to the first implant 102 relative to the second implant 104 . ) (and/or vice versa). In some embodiments, the adjustment mechanism 108 is an eye splice (ie, a finger trap), while in other embodiments, the adjustment mechanism 108 is a sliding knot. )to be. The adjustment mechanism 108 may be a one-way adjustable locking structure. In one embodiment, the locking mechanism 116 is a pierce hitch. However, the locking mechanism 116 may be any fixed locking structure, such as a knot.

As shown in FIG. 2 , the first and second implants 102 , 104 are rectangular such that they lie flat against the damaged tissue. However, implants 102 , 104 may have any other geometric configuration. The first and second implants 102 , 104 may be constructed from suture material, plastic, or any other suitable surgical material. As shown in FIG. 2 , each implant 102 , 104 has a pair of adjacent and spaced apart apertures 110 . In the depicted embodiment, a pair of adjacent and spaced-apart openings 110 extend through a first side 112 of the implant 102 , 104 to a second side 114 of the implant 102 , 104 . . When the anchor system 100 is in a deployed configuration, the implants 102 , 104 have radial saddles 112 between the openings 110 to hold them across the suture line 106 .

Turning now to FIGS. 3A-3D , there is shown a perspective view of a schematic representation of a method for creation of a locking mechanism 116 in a suture 106 strand, according to one embodiment. In the embodiment shown in FIGS. 3A-3D , the locking mechanism 116 is a pierce hitch. To create the pierce hitch 116 , a hole 118 is formed in the suture 106 strand between the first end 120 and the second end 122 . A threader 124 or other similar device is positioned through the hole 118 in the suture 106 strand as shown in FIG. 3A . Thereafter, as shown in FIG. 3B , the first end 120 of the suture line 106 is threaded or weave through the threader 124 . The threader 124 is then pulled through the hole 118 in the suture 106 strand creating a loop 125 in the suture 106 as can be seen in FIG. 3C . To minimize the loop 125, the first end 120 of the suture 106 is tensioned by creating a pierce hitch 116 as shown in FIG. 3D.

Referring now to FIG. 4 , there is shown a perspective view of a schematic representation of a suture strand 106 connected to a second implant 104 , according to one embodiment. In the depicted embodiment, the second implant 104 includes a pair of adjacent and spaced apart openings 110 . The second end 122 of the suture 106 strand is first passed through one of the adjacent, spaced apart openings 110 from the first side 112 of the implant 104 . The second end 122 of the suture 106 strand is then passed from the second side 114 of the implant 104 through the other adjacent, spaced-apart openings 110 such that the middle portion of the suture line 106 is passed. 128b extends between adjacent, spaced-apart openings 110 on the second side 114 of the implant 104 (above the radial saddle 112 ). Finally, as shown in FIG. 4 , the second end 122 of the suture 106 strand is passed through the pierce hitch 116 such that a “pierce hitch tail” 121 is formed on the suture 106 . The “tensile limb” 123 extends to the second end 120 of the suture 106 and 122 to the second end of the suture line 106 . Pierce hitch 116 functions as a self-collapsing noose near pierce hitch tail 121 and is fixed in relation to the position of adjustment mechanism 108 (FIG. 1).

Turning now to FIG. 5 , a perspective view of a schematic representation of an anchor system 100 according to an embodiment is shown. From the configuration shown in FIG. 4 , the first implant 102 is connected to the suture 106 strand. A second end 122 of the suture 106 strand is passed from the second side 114 of the implant 102 through one of a pair of adjacent spaced apart openings 110 . The second end 122 (ie, tensile limb 123 ) of the suture strand 106 is then from the first side 112 of the implant 102 through other adjacent, spaced-apart openings 110 . The intermediate position 128a ( FIG. 6 ) of the suture line 106 is passed between adjacent, spaced-apart openings 100 on the first side 122 of the implant 102 (radial saddle 112 ). above) is extended. Finally, the second end 122 of the suture 106 strand (ie, the tensile limb 123 ) is passed through the adjustment mechanism 108 . Tension rim 123 may slide in relation to pierce hitch tail 121 (because pierce hitch tail 121 does not slide).

Referring now to FIG. 6 , a perspective view of a schematic representation of an anchor system 100 according to an embodiment is shown. As shown in the depicted embodiment, the adjustment mechanism 108 is an eye splice. The eye splice 108 is formed from the suture 106 strand and the second end 122 (ie, the tensile limb 123 ) of the suture 106 strand is passed through the eye splice 108 so that the first Create an adjustment loop 126 at the suture 106 between the implant 102 and the eye splice 108 . Therefore, in the pre-deployment configuration, the intermediate position 128a extends between the openings 110 on the first side 112 of the first implant 102 and the intermediate position 128b is the second position of the second implant 104 . It extends between the openings 110 on the two sides 114 with an eye splice 108 and a pierce hitch 116 between them. To adjust the adjustment loop 126 (ie, change its diameter), the second end 122 of the suture line 106 is pulled, bringing the first implant 102 and the second implant 104 closer together. move it

Turning now to FIGS. 7-10 , views of various schematic representations of an anchor system 100 according to alternative embodiments are shown. 7 shows a side view of an anchor system 100 according to an alternative embodiment wherein the first and second implants 102 , 104 are intubation anchors (or any other tubular structures). The intubation anchors 102 , 104 are constructed of a soft material, such as a suture material. In the depicted embodiment, the suture 106 strand is folded in half, creating a sliding limb 123 and a non-slip limb 121 (i.e., the interstitial limb 123 and the pierced hitch tail 121).

With continued reference to FIG. 7 , a strand of suture 106 is passed through the first and second intubation anchors 102 , 104 . Knot 116 is used to attach second intubation anchor 104 to non-slip limb 121 . An eye splice 108 is formed in the non-slip limb 121 between the first and second intubation anchors 102 , 104 . The first intubation anchor 102 is slidably connected to a suture line 106 (sliding limb 123 ). As shown in FIG. 7 , the sliding rim 123 is then passed through the eye splice 108 , creating an adjustment loop 126 .

8 and 9 show perspective views of a schematic representation of the anchor system 100 of FIG. 7 . In FIG. 8 , a first intubation anchor 102 is attached to a suture 106 by passing an adjustment loop 126 through a slit 130 (or a segment of another portion) in the first intubation anchor 102 . It is easily attached to the slide. Specifically, as shown in FIG. 8 , the adjustable loop segment 102 passes through the slit 130 in the first intubation anchor 102 and exits out of the side 132 of the anchor 102 . Then, as shown in FIG. 9 , the adjustable loop segment 126 is passed over the distal end 134 of the first intubation anchor 102 , thereby lassoing it.

10 shows a perspective view of a schematic representation of an anchor system 100 according to another alternative embodiment. The implants 102 , 104 in FIG. 10 are also intubation anchors (or any other tubular structures). In the depicted embodiment, the intubation anchors 102 , 104 are constructed from a braided material. A strand of suture 106 adjustably connects the first intubation anchor 102 and the second intubation anchor 104 . In one embodiment, the suture 106 strand is a 2-0 suture, although other types of suture may be used. The suture 106 strand is folded in half (as also shown in FIG. 7) so that both ends 120, 122 terminate on the same side and the other end forms a “U” shape. A second intubation anchor 104 is secured to the suture 106 through a knot 116 at the suture 106 strand. As in the previous embodiment of the anchor system 100 , the eye splice 108 is formed in the locking rim 121 (also referred to herein as a non-slip rim or pierce hitch tail) of the suture 106 strand. The other limb, tension limb 123 , is passed through eye splice 108 and forms an adjustment loop 126 . Similar to the anchor system 100 shown in FIGS. 8 and 9 , an adjustment loop 126 extends around the distal end 134 of the first intubation anchor 102 .

Referring now to FIGS. 11-17 , views of various schematic representations of a delivery device 200 are shown, according to one embodiment. The delivery device 200 is configured to store therein one or more anchor systems 100 for deployment. 11 shows a perspective view of a delivery device 200 . The delivery device 200 includes an elongated body 202 having a proximal end 204 and a distal end 206 . The delivery device 200 includes an introducer sleeve 210 and a stop that are adjustable with a positive locking mechanism (not shown) extending from the distal end 206 of the elongated body 102 . (stop) (not shown). The needle 212 extends distally from within the introducer sleeve 210 . The anchor system 100 ( FIG. 6 ) is fully positioned at the needle 212 of the delivery device 200 . The intubation pusher rod 208 extends within the lumen 232 of the needle 212 of the delivery device 200 . As detailed below, the purpose of the intubation pusher rod is to push the anchor system 100 away from the delivery device 200 . The elongated body 202 additionally includes an actuator 214 and a locking mechanism 216 .

Turning now to FIG. 12 , there is shown a perspective view of schematic representations of the pusher assembly 220 of the delivery device 200 according to an embodiment. The pusher assembly 220 includes a pusher body 218 and an intubation pusher rod 208 extending distally therefrom. The pusher body 218 includes an actuator 214 . In the depicted embodiment, the actuator 214 is a thumb slide. The intubation pusher rod 208 includes a relieved area 222 between the distal end 224 of the pusher assembly 220 and the pusher body 218 . Relief region 222 is where a portion of intubation pusher rod 208 is removed. Relief area 222 allows for easy rounding of corners or bends formed in needle 212 .

With continued reference to FIG. 12 , the intubation pusher rod 208 also includes a slit 226 at the distal end 224 of the pusher assembly 220 . As can be seen, a slit 226 extends from the relief region 222 to the distal end 224 of the intubation pusher rod 208 . This allows the ends 120 , 122 of the suture line 106 to be positioned within the slit 226 . The intubation pusher rod 208 can then be pulled proximally towards an opening 228 ( FIG. 17 ) of the needle 212 , the intubation pusher rod 208 and the lumen 232 of the needle 212 . Create a pinch point 230 in between and provide ends 120 , 122 of seam 106 .

Turning now to FIGS. 13-17 , side views are shown of schematic representations of a delivery device 200 in various structures according to an embodiment. In the first configuration, the actuator 214 is a first distance from the distal end 206 of the elongated body 202 as shown in FIG. 13 . In a first configuration, the delivery device 200 is prepared for deploying the anchor system 100 . In the second configuration, the actuator 214 is a second distance from the distal end 206 of the elongated body 202 as shown in FIG. 14 . In one embodiment, the first distance is greater than the second distance. Upon moving from the first configuration to the second configuration, the first implant 102 is deployed. Thus, by moving the actuator 214 (thumb slide) distally along the elongated body 202 , the first implant 102 is deployed.

13 and 14, in both the first and second configurations, the locking mechanism 216 is in the locked position. In the depicted embodiment, the lockout mechanism 216 is a lockout switch. The lock switch 216 may be slidable or otherwise movable between a locked position and an unlocked position. When in the locked position, as shown in FIGS. 13 and 14 , the actuator 214 cannot advance distally from the second configuration in FIG. 14 . The actuator 214 cannot advance distally along the elongated body 202 past the lock switch 216 . 15 , the lock switch 216 can be moved to a depressed and locked position.

As in FIG. 15 , when the lock switch 216 is in the locked position, the actuator 214 circles a third distance from the distal end 206 of the elongated body 202 to achieve the third configuration in FIG. 16 . can move upwards. Upon moving from the second configuration to the third configuration, the pusher rod 208 extends out of the needle 212 to deploy the second implant 104 . In the third configuration, as shown, the relief area 222 is exposed between the pusher rod 208 and the needle 212 .

In a third configuration, the suture line 106 can be moved into the relief region 222 between the pusher rod 208 and the needle 212 . With the end(s) 120 , 122 of the suture 106 extending through the relief region 222 , the delivery device 200 may be moved from the third configuration to the fourth configuration. To move the delivery device 200 from the third configuration to the fourth configuration, the actuator 214 is pulled in the proximal direction. When the delivery device 200 moves from the third configuration to the fourth configuration ( FIG. 17 ), the intubation pusher rod 208 is retracted behind the needle 212 and the end(s) 120 , 122 of the suture line 106 . This allows the needle 212 to be cut.

Referring now to FIGS. 18-22 , various views of a schematic representation of a delivery device 200 in accordance with an alternative embodiment are shown. 18 and 19 show an optional latching slide 219 and a tensioning wheel 221 of the elongated body 202 of the delivery device 200 . The delivery device 200 also includes an actuator 214 on the opposite side of the elongated body 202 in relation to the latching slide 219 . As shown in FIG. 20 , a rack 234 in the elongated body 202 connects the intubation pusher rod 208 and moves the intubation pusher rod 208 in and out of the needle 212 .

With continued reference to FIG. 20 , the actuator 214 includes a ratchet mechanism to selectively advance the intubation pusher rod 208 . When the actuator 214 is pulled in the proximal direction, the rack 234 moves distally and drives the intubation pusher rod 208 in the distal direction. The actuator 214 may have a spring return to return it back to the first (or starting) configuration when the actuator 214 is released. Tension wheel 221 extends partially through elongate body 202 such that a suture 106 extending within needle 212 can wrap around tension wheel 221 . When the implants 102 , 104 are deployed, the tension wheel 221 provides traction on the suture line 106 . In the depicted embodiment, the tension wheel 221 includes teeth 223 to grip the seam 106 . A latching slide 219 is optional and may be used to selectively lock the tension wheel 221 to rotation.

19 and 22 , in the first configuration, the intubation pusher rod 208 extends within the needle 212 . As shown in FIG. 21 , the delivery device 200 may be moved from a first configuration to a second configuration. To move the delivery device 200 from the first configuration to the second configuration, the actuator 214 is squeezed or pulled in the proximal direction. Proximally moving the actuator 14 drives the rack 234 distally and consequently pushes the intubation pusher rod 208 distally out of the needle 212 and the first implant 102 into the needle 212 . expelling from The actuator 214 can be released and then pulled back proximally when it is time to eject and deploy the second implant 104 . The actuator 214 may also be held in the second configuration ( FIG. 21 ) by holding the actuator 214 proximally, exposing the relief region 222 . With the relief area 222 exposed, the ends 120 , 122 of the suture line 106 may extend into the relief area 222 . When the actuator 214 is then released ( FIG. 22 ), the end(s) 120 , 122 of the suture 106 are cut relative to the needle 121 .

Referring now to FIGS. 23-25 , various views of a schematic representation of an anchor system 100 at various stages between a pre-deployment configuration and a deployed configuration are shown in accordance with an alternative embodiment. As described above, the anchor system 100 ( FIG. 6 ) is fully positioned within the needle 212 of the delivery device 200 . For example, first implant 102 is loaded distally from needle 212 in relation to second implant 104 with pierce hitch tail 121 and tension rim 123, pierce hitch tail 121 and tensile limb 123 extend proximally within the delivery device 200 therefrom. (Note that multiple anchor systems 100 are to be loaded into the delivery device 200 together with the first implant 102 of the additional anchor system 100 behind the second implant 104 of the main anchor system 100 . should be considered.)

In one embodiment, the pierce hitch tail 121 is releasably coupled to the delivery device 200 and functions as a tether used to control delivery of the second implant 104 and the first implant 102 . Apply traction to To deploy the anchor system 100 , the delivery device 200 is placed on the first side 302 of the tissue 300 or other object. 23 , tissue 300 includes tear 304 (or cut or other tissue wound). In a first configuration, delivery device 200 is disposed on first side 302 and tear 304 of tissue 300 . The needle 212 is advanced through the tissue 300 and tear 304 at the first piercing site 308 and out of the second opposite surface 306 of the tissue 300 ( FIG. 29 ).

With the needle 212 on the second side 306 of the tissue 300, the actuator 214 is engaged, eg, the thumb slide 214 is advanced distally along the elongated body 202; Drive the intubation pusher rod 208 distally to achieve the second configuration. 23 , in the second configuration, the intubation pusher rod 208 pushes the first implant 102 away from the delivery device 200 and is deployed on the second side 306 of the tissue 300 . The needle 212 is then withdrawn from the first piercing site 308 on the first side 302 of the tissue 300 ( FIGS. 30 and 31 ). In one embodiment of the delivery device 200 shown in FIGS. 18-22 , the suture 106 may be traction by the tension wheel 221 as the needle 212 is retracted. The needle 212 may then be moved to a second piercing site 310 (adjacent to the first piercing site 308 ) on the first side 302 of the tissue 300 and tear 304 ( FIG. 32).

The needle 212 is then advanced through the first side 302 , the tear 304 , and the second side 306 of the tissue 300 at the second piercing site 310 ( FIGS. 33-35 ). With the needle 212 on the second side 306 of the tissue 300 , the delivery device 200 is moved in third and fourth configurations. From the second configuration, the lock switch 216 is depressed or otherwise engaged to allow further distal movement of the actuator 114 . With the lock switch 216 in the locked position, the actuator 114 is moved distally to the third configuration and drives the intubation pusher rod 208 distally again. 23 , in the third configuration, the intubation pusher rod 208 pushes the second implant 104 away from the delivery device 200 and it is deployed.

At any time after the second implant 104 is deployed, the pierce hitch tail 121 can be released (ie, embrace the tether and traction) and allow the delivery device 200 to be removed, ie, the needle 212 . is pulled back to the first side 302 of the tissue 300 through the second piercing site 310 . As the anchor system 100 is deployed, the anchor system 100 moves the first side 302 of the tissue 300 and the second side 306 of the tissue 300 together to close the tear 304 . can be used for To do this, the adjustable loop 126 is tightened (ie, the diameter of the adjustable loop 126 is reduced) or otherwise the second end 122 of the suture 106 (or the tension limb 123). ) by pulling/tensioning (FIGS. 36-38). Tension of the second end 122 pulls both the implants 102 , 104 toward the second side 306 of the tissue 300 , reducing the suture 106 strands therebetween. In FIG. 23 , two anchor systems 100 are shown, each with a different adjustment mechanism 108 . The anchor system 100 on the left includes a sliding knot 108A and the anchor system 100 on the right includes an eye splice 108B. Eye splice 108B (and sliding knot 108A) locks first implant 102 in position relative to second implant 104 . The pierce hitch 116 maintains the position of the second implant 104 along the suture line 106 .

After the desired compression has been achieved (between the first implant 102 and the second implant 104) and continuing with the delivery device 200 in a third configuration, the relief region 122 is coupled to the intubation pusher rod 208 and It is exposed between the needles 212 . The delivery device 200 may be rotated or otherwise adjusted to receive the over tension limb 123 in the relief region 122 . The actuator 114 can then be re-engaged, eg, to slide the thumb slide 114 back (toward the proximal end 204 of the elongated body 202 ) in the proximal direction. Proximally moving the actuator 214 pulls the intubation pusher rod 208 proximally into the needle 212 and allows the excess tension limb 123 to be cut relative to the needle 212 and removed. The same process may be repeated (or may occur concurrently) leaving any excess pierce tail 121 . The resulting deployed configuration of the anchor system 100 is shown in FIGS. 26-28 . 24 and 25 show alternative embodiments, wherein the implants 102, 104 are intubation anchors.

All definitions, defined and used herein, are to be understood as controlling the dictionary definitions, the definitions in the document incorporated by reference, and/or the ordinary meanings of the defined terms.

While various embodiments have been described and shown herein, those skilled in the art will readily configure various other means and/or structures for carrying out the functions and/or obtaining the results and/or one or more advantages described herein. will, and each such variation and/or modification is considered to be within the scope of the embodiments described herein. More generally, such skilled artisan will recognize that all variables, dimensions, materials, and configurations depicted herein are meant to be illustrative and that actual variables, dimensions, materials, and/or structures are not intended to be used in the teachings. It will readily be appreciated that it will depend on the particular application or applications. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. Therefore, it is to be understood that the foregoing embodiments are presented by way of example only, and that, within the scope of the appended claims and their equivalents, the embodiments may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. Moreover, if such features, systems, articles, materials, kits, and/or methods are inconsistently with each other, then the characteristics, systems, articles, materials, and/or methods of such features, systems, articles, materials, and/or methods are inconsistent with each other. Any combination of two or more is included within the scope of the present disclosure.

The terminology used herein is for the purpose of description of specific embodiments only and is not intended to limit the invention. As used herein, singular forms (including the above) are not intended to include plurals, unless the context clearly indicates otherwise. The words "include" (and include in some form, such as "includes"), "have" (and have some form of having, such as "having"), "include" (in some form, such as "includes"). The term should be further understood as open connective verbs. Consequently, a method or device “comprises”, “has”, or “contains” one or more steps or elements. Likewise, a step of a method or element of a device that “comprises,” “has,” or “contains” one or more features has one or more of those features, but does not incorporate the one or more features. It is not limited to just having. Moreover, a device or structure configured in a particular method may be configured at least in such a way but not in methods not listed.

In any case, all means and steps claimed below, as well as corresponding structures, materials, acts and equivalents of functional elements, are specifically claimed in any structure, material for performing a function in combination with other claimed elements. or acts. The description of the present invention is presented for purposes of illustration and depiction, but is not intended to be exhaustive or limited to the form disclosed. Many variations and modifications will become apparent to those skilled in the art without departing from the scope and spirit of the invention. The present embodiments were chosen and depicted in order to better explain the principles of one or more aspects of the invention and its practical application, as suitable for the particular use contemplated, and to which others skilled in the art may use for various embodiments with various modifications. It enables one or more aspects of the invention to be understood.

Claims (20)

In the anchor system,
a first implant connected to a suture strand, wherein the suture strand is folded such that a tensile limb extends from the first implant and a locking limb extends from the first implant;
a second implant fixed to the locking rim; and
an adjustment mechanism at the suture strand between the first implant and the second implant;
and the tension rim is passed through the adjustment mechanism. According to claim 1,
and an adjustment loop at the suture strand extending from the adjustment mechanism through the first implant. According to claim 1,
wherein the adjustment mechanism is an eye splice. 3. The method of claim 2,
and the eye splice is on the locking rim. According to claim 1,
and the second implant is secured to the lock rim via a pierce hitch at the lock rim. 6. The method of claim 5,
wherein the pierce hitch is formed by inserting an end of the locking rim through a hole in the locking rim. According to claim 1,
wherein the first implant and the second implant are rectangular. According to claim 1,
and a pair of spaced-apart adjacent openings in each of the first and second implants. 9. The method of claim 8,
and a radial saddle between each opening of the pair of spaced-apart adjacent openings. 9. The method of claim 8,
wherein the suture strand extends through the pair of spaced apart and adjacent openings in each of the first and second implants. A delivery device comprising:
an elongated body with a needle, the needle extending distally from the elongated body;
a pusher assembly within the elongated body, the pusher assembly including an intubated pusher rod extending distally from the pusher body and an actuator extending from the pusher body through the elongated body; and
a locking mechanism on the elongated body, wherein the locking mechanism is movable between a locked position and an unlocked position; including,
the intubation pusher rod is slidable within the needle;
when the locking mechanism is in the locked position the actuator is movable from the first configuration to the second configuration and when the locking mechanism is in the unlocked position the actuator is movable from the second configuration to the third configuration , the delivery device. 12. The method of claim 11,
and a relief region between the distal end of the pusher rod and the pusher body. 13. The method of claim 12,
and a slit extending from the relief region to the pusher rod. 12. The method of claim 11,
and a pinch point between the intubation pusher rod and the lumen of the needle. The device of claim 11 , wherein the actuator is a thumb slide. In the meniscus treatment method,
an elongated body having a needle, the needle extending distally from the elongated body, a pusher assembly in the elongated body, the pusher assembly extending from the pusher body through an intubating pusher rod extending distally from the pusher body and the elongated body providing a delivery device comprising an actuator, said intubation pusher rod slidable within said needle, and a locking mechanism on said elongated body, said locking mechanism being movable between a locked position and an unlocked position. step;
a first implant connected to a suture strand, wherein the suture strand is folded such that a tensile rim extends from the first implant and a locking limb extends from the first implant; a second implant secured to the locking rim; and the first implant. and an adjustment mechanism at said suture strand between said second implants, said tensioning limb passing through said adjustment mechanism;
positioning the needle at a first piercing site on a first side of tissue;
piercing the needle through the first piercing site to a second side of the tissue;
distally moving the actuator and deploying the first implant from the delivery device;
removing the needle from the first piercing site on the first side of the tissue;
positioning the needle at a second piercing site on a second side of the tissue;
piercing the needle through the first piercing site to a second side of the tissue;
moving the locking mechanism from the locked position to the unlocked position;
distally moving the actuator further and deploying the second implant from the delivery device. 17. The method of claim 16,
The method further comprising the step of pulling the tension limb. 18. The method of claim 17,
wherein the step of pulling the tension limb pulls the first and second implants towards the second side of the tissue. 18. The method of claim 17,
The method further comprising the step of positioning the tension limb between the intubation pusher rod and the needle. 20. The method of claim 19,
The method further comprising the step of moving the actuator proximally and cutting the tension limb between the intubation pusher rod and the needle.

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